Thursday, October 09, 2008

FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?

As reported in today's AdAge, "Bayer Healthcare Pharmaceuticals is pulling a 60-second ad for birth-control pill Yaz. The move comes after the U.S. Food and Drug Administration expressed concerns that two ads for the drug go too far in suggesting the drug could help overcome PMS and acne" (see "Bayer to Pull Yaz Ad After FDA Warning").

The FDA criticized the ad, 'Balloons,' which is still in rotation and can be seen on the YAZ product website (see image above; click for enlarged view). "The warning letter said that while Yaz had been approved as a contraceptive and a treatment for PMDD (premenstrual dysphoric disorder) and in some cases for acne, the TV ads could be viewed as suggesting the drug also remedied PMS and broader conditions of acne."

This broadcast DTC (direct-to-consumer) ad has been around for quite some time and I'm sure everyone that Bayer wished to reach by the ad has seen it at least once, maybe several times. So, this warning letter is just another example of the FDA closing the barn door after the cow has left (see, for example, "Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!").

But, more importantly, the FDA clearly reviewed the storyboards for this ad long BEFORE it was aired. In fact, FDA offers the storyboards as evidence along with the warning letter on its website. I've captured part of the storyboard that shows the balloons:

My question is this: If the FDA is going to preview broadcast DTC ads AND get paid to do it, why didn't the agency stop the YAZ ad from being produced or aired after seeing this storyboard? Is FDA THAT slow in issuing warning letters? Or is it in cahoots with drug companies to help them avoid complying with regulations? Who needs a regulatory agency that regulates AFTER the fact and not before?

This can only get WORSE when drug companies routinely pay for FDA to preview their ads.

4 comments:

We often see advertisements on television for some type of medication — usually one involved in a large-market disease and the commercial is sponsored by a big pharmaceutical company. This is called direct to consumer (DTC) advertising, and doctors would prefer they did not exist.Since 1997, when the FDA relaxed regulations regarding this form of advertising, the popularity of these commercials greatly increased. Now, the pharmaceutical industry spends around $5 billion annually on this gigantic media effort. Normally, the commercial airs within a year of the drug’s approval, which raises safety concerns and involves money spent that could be applied to greater uses, according to many. But, we are dealing with a corporation here. The purpose of DTC ads i s not education, in my opinion, as others have claimed. Any advertising of any type shares the same objective — to increase sales and grow their market — in this case, for a particular perceived medical condition or disease state. The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment for what may be an unconfirmed medical condition. The most interesting ones are for erectile dysfunction (ED) during primetime TV, with the real possibility of children watching. Further surreal is that these particular commercials seem to have ED sufferers portrayed as those who could probably run marathons, which is not realistic from a clinical perspective.DTC advertising is also a catalyst for and similar to disease mongering. Disease mongering is the creation of what some believe to be medical flaws. It is illustrated by the drug companies through exaggeration and embellishments via various media sources as an avenue for propaganda — often seen with DTC advertising. Though the flaws may not be medical, the corporate creation of these questionable human ailments that do not require treatment, possibly, may be an attempt to develop a particular medical condition to acquire profit.One of my favorite DTCs is the new indication for the use of an anti-depressant for a social disorder. This used to be called introversion, a term created by Dr. Carl Yung. It is a personality trait, not a medical disease. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators wish to grow the market for a particular, and possibly fictional, disease state. Then there is baldness treatments being advertised, as another example. Lifestyle meds are not treatment meds for illnesses, and should not be portrayed as such.Also, DTC ads normally discuss a single treatment option when likely several treatment options exist for authentic medical disorders. This should be left to the discretion of the physician, as they assess your health, not your TV or another media source. That’s why most of the world does not conduct DTC advertising, with the exception of America and New Zealand.Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professionals remains largely unregulated, yet apparently effective for the DTC creators. People are prone to believe what they see and hear, regardless of whether or not it is actually true. After viewing a DTC ad, many seek out a doctor visit and request whatever product that was advertised, which makes the doctor’s situation quite cumbersome. So the doctor and patient relationship is altered in a negative fashion since most DTC advertised drugs require a prescription.Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world. Perhaps this will save some of our over-prescribing habits, which will benefit all of us in the long term. And the health care system can regain control of its purpose, which is far from financial prosperity.

Men of ill judgment oft ignore the good that lies within their hands till they have lost it.— Sophocles

Although it is industry standard to request DDMAC review of new TV ads before they are aired, there is no requirement for companies to do so. I don't know if these YAZ ads were precleared, though since a letter was issued, they probably were not. But this wasn't a case of FDA failing to comply with regulations, since the regulations you're referring to simply don't exist.

BTW, the user fee program for review of DTC ads was cancelled in January because Congress would not appropriate the funds:

I am referring to regulations cited in the FDA letter about the ads in question, not about regulations to review DTC ads prior to airing.

If the ad was not submitted for review BEFORE it was aired, how is it that the FDA has the storyboards? Do companies voluntarily submit storyboards AFTER the ads are aired? If so, this just proves my point, except that the companies are making a laughing stock out of the FDA!

All drug companies are required by law to submit any promotional material to DDMAC "at the time of first use" together with a form called Form 2253. Sometimes if the company had failed to submit the piece at the time it was first used, you'll see that noted in the letter itself as a violation (for example, www.fda.gov/Cder/warn/2004/macmis12335.pdf).

This requirement to submit at tiem of first use includes all TV ads, where customarily, a company would submit both a video and a storyboard. That's how FDA has the storyboards...

Mind you, I'm not excusing the ads here, just clarifying what the facts are regarding FDA's review of promotional materials, DTC in particular.